Actively Recruiting
A Phase 1, Multicenter, Open-Label Study of CC-97540 (BMS-986353) CD19-Targeted Nex-T CAR T Cells in Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-06-03
270
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead Sponsor
B
Bristol-Myers Squibb Services Unlimited Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability, initial effectiveness, and how the body processes CC-97540 in adults with severe and hard-to-treat autoimmune diseases, including systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis. This Phase 1 study aims to gather important safety data and early signs of benefit from this new treatment approach. Participants receive CC-97540, a CD19-targeted Nex-T CAR T cell therapy, along with other medications such as fludarabine, cyclophosphamide, and tocilizumab. These drugs are given in specified doses on scheduled days to prepare the body and support the CAR T cell therapy. The study is open-label and multicenter, focusing on finding the recommended dose for future research. During the study, participants are closely monitored for up to two years after receiving CC-97540. Researchers track adverse events, serious reactions, laboratory changes, and dose-limiting toxicities. They also assess disease activity, symptom improvements, lung function, and drug levels in the blood at various time points, including detailed evaluations at week 24. This comprehensive monitoring helps determine the treatment's safety and potential benefits over time.
CONDITIONS
Brief Title
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of systemic lupus erythematosus meeting 2019 EULAR/ACR criteria with specific autoantibodies
- Active SLE disease with major organ involvement and inadequate response to at least two standard treatments
- Diagnosis of idiopathic inflammatory myopathy meeting 2017 EULAR/ACR criteria with specific antibodies
- Moderate to severe muscle and/or skin involvement in IIM with proof of activity
- Inadequate response to at least two standard treatments for IIM
- Diagnosis of systemic sclerosis meeting 2013 EULAR/ACR criteria and positive for antinuclear antibodies
- Diffuse or limited cutaneous systemic sclerosis with progressive interstitial lung disease and inadequate response to at least one treatment
- Rheumatoid arthritis with at least 3 swollen and 3 tender joints or progressive interstitial lung disease
- Inadequate response or intolerance to at least one conventional synthetic DMARD and at least two other DMARDs with different mechanisms of action
You will not qualify if you...
- Diagnosis of drug-induced systemic lupus erythematosus
- Presence of other systemic autoimmune diseases such as multiple sclerosis, psoriasis, or inflammatory bowel disease
- Overlap syndromes including rheumatoid arthritis, scleroderma, or mixed connective tissue disease in SLE
- Significant central nervous system pathology within the past 12 months
- Exclusion of other forms of inflammatory myopathy such as inclusion body myositis or juvenile myositis
- Severe muscle damage or cardiac involvement in idiopathic inflammatory myopathy
- Systemic sclerosis with pulmonary arterial hypertension requiring active treatment
- Rapidly progressive systemic sclerosis with severe gastrointestinal involvement
- History of scleroderma renal crisis
- History or current inflammatory joint disease other than rheumatoid arthritis
- Joint damage or deformity interfering with disease activity assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years after CC-97540 infusion
Participants receive CC-97540 and other specified drugs as part of the treatment for severe, refractory autoimmune diseases.
Visits occur according to the treatment schedule up to 2 years
Duration - Up to 2 years after CC-97540 infusion
Participants are monitored for safety, treatment response, and adverse events after treatment ends.
Regular visits for up to 2 years
Trial Site Locations
Total: 54 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Local Institution - 0048
New Haven, Connecticut, United States, 06520
Withdrawn
4
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
6
Local Institution - 0053
Chicago, Illinois, United States, 60612
Active, Not Recruiting
7
Local Institution - 0030
Baltimore, Maryland, United States, 21287
Withdrawn
8
Local Institution - 0038
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
9
Local Institution - 0046
Boston, Massachusetts, United States, 02115
Withdrawn
10
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
11
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109-2800
Actively Recruiting
13
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States, 48202
Actively Recruiting
14
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Local Institution - 0028
Omaha, Nebraska, United States, 68198
Completed
17
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
18
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
19
Local Institution - 0054
New York, New York, United States, 10021
Withdrawn
20
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
21
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
22
Local Institution - 0055
New York, New York, United States, 10065
Withdrawn
23
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
24
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
Local Institution - 0027
Columbus, Ohio, United States, 43203
Withdrawn
26
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
27
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
28
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
29
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
30
Local Institution - 0057
Seattle, Washington, United States, 98105
Not Yet Recruiting
31
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
32
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
33
Local Institution - 0043
Strasbourg, Alsace, France, 67098
Withdrawn
34
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France, 33600
Actively Recruiting
35
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France, 34295
Actively Recruiting
36
Hopital Claude Huriez - CHU de Lille
Lille, France, 59037
Actively Recruiting
37
Local Institution - 0040
Nice, France, 06202
Completed
38
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
39
Local Institution - 0052
Paris, France, 75679
Withdrawn
40
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
41
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
42
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
43
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
44
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
45
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
46
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
47
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
48
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168
Actively Recruiting
49
Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
50
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
51
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
52
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
53
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
54
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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